Trial document

drksid header

DRKS-ID: DRKS00013614

Trial Description

start of 1:1-Block title

Title

cENZIAN versus ENZIAN – An observational multicenter study on
the prediction of a preoperative to an intraoperative ENZIAN classification for
endometriosis surgery.

end of 1:1-Block title

start of 1:1-Block acronym

Trial Acronym

cENZIAN-Trial

end of 1:1-Block acronym

start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url

start of 1:1-Block public summary

Brief Summary in Lay Language

This study should serve as a review whether the results of a postoperative
performed disease classification ("ENZIAN" classification) are predictable by the preoperative application of this classification ("cENZIAN") in patients with endometriosis. This study is important because in recent years, the importance of preoperative diagnostics in deep infiltrating endometriosis has increased significantly. The planned number of participants is 900-1000 patients. The study is a pure observational study without risk for the study participants.

end of 1:1-Block public summary

start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

This multicenter study should serve as a review whether the results of a postoperative
performed disease classification ("ENZIAN" classification) are predictable by the preoperative application of this classification ("cENZIAN") in patients with endometriosis. This study is important because in recent years, the importance of preoperative diagnostics in deep infiltrating endometriosis has increased significantly. The study is to be classified as a non-interventional method study (classification of the cENZIAN classification as a new diagnostic method without any risk for the study participants). The planned number of participants is 900-1000 patients.

end of 1:1-Block scientific synopsis

start of 1:1-Block forwarded Data

Do you plan to share individual participant data with other researchers?

end of 1:1-Block forwarded Data

start of 1:1-Block forwarded Data Content

Description IPD sharing plan:

[---]*

end of 1:1-Block forwarded Data Content

start of 1:1-Block organizational data

Organizational Data

DRKS-ID: DRKS00013614
Date of Registration in DRKS: 2017/12/22
Date of Registration in Partner Registry or other Primary Registry: [---]*
Investigator Sponsored/Initiated Trial (IST/IIT): yes
Ethics Approval/Approval of the Ethics Committee: Approved
(leading) Ethics Committee No.: 1002/2017, Ethikkommission des Landes Oberösterreich

end of 1:1-Block organizational data

start of 1:n-Block secondary IDs

Secondary IDs

[---]*

end of 1:n-Block secondary IDs

start of 1:N-Block indications

Health Condition or Problem studied

ICD10: N80 - Endometriosis

end of 1:N-Block indications

start of 1:N-Block interventions

Interventions/Observational Groups

Arm 1: In patients with a planned endometriosis surgery, the common diagnostic measures are carried out routinely (depending on the use or need: palpation/speculum, ultrasound, MRI or further imaging), regardless of the study. The responsible physician will then fill out the section "cENZIAN" in the questionnaire for each diagnostic measure. At the end of the surgical procedure, the surgeon records his intraoperative impressions under the heading "ENZIAN". This concludes the study participation of the patient.

end of 1:N-Block interventions

start of 1:1-Block design

Characteristics

Study Type: Non-interventional
Study Type Non-Interventional: Observational study
Allocation: Single arm study
Blinding: Open (masking not used)
Who is blinded: [---]*
Control: Uncontrolled/Single arm
Purpose: Diagnostic
Assignment: Single (group)
Phase: N/A
Off-label Drug use: N/A

end of 1:1-Block design

start of 1:1-Block primary endpoint

Primary Outcome

end of 1:1-Block primary endpoint

start of 1:1-Block secondary endpoint

Secondary Outcome

[---]*

end of 1:1-Block secondary endpoint

start of 1:n-Block recruitment countries

Countries of Recruitment

AT: Austria
DE: Germany
CZ: Czech Republic
CH: Switzerland

end of 1:n-Block recruitment countries

start of 1:n-Block recruitment locations

Locations of Recruitment

University Medical Center Kepler Universitätsklinikum, Linz
University Medical Center Universitätsklinik für Frauenheilkunde, Bern
University Medical Center Universitätsklinikum Tübingen, Tübingen
Medical Center Landesklinikum Melk, Melk
Medical Center UPMD, Prag
University Medical Center Universitätsklinikum Münster, Klinik für Frauenheilkunde und Geburtshilfe, Münster
Medical Center St.Anna Hospital Herne, Klinik für Frauenheilkunde & Geburtshilfe, Herne
University Medical Center Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden, Dresden
University Medical Center Medizinische Universität Innsbruck, Department Frauenheilkunde, Universitätsklinik für Gynäkologische Endokrinologie und Reproduktionsmedizin, Innsbruck
University Medical Center Medizinische Hochschule Hannover (MHH), Klinik Frauenheilkunde und Geburtshilfe, Hannover
Medical Center Evangelisches Krankenhaus Bethesda Mönchengladbach, Mönchengladbach
Medical Center St. Johannes Hospital, Dortmund

end of 1:n-Block recruitment locations

start of 1:1-Block recruitment

Recruitment

Planned/Actual: Actual
(Anticipated or Actual) Date of First Enrollment: 2018/01/16
Target Sample Size: 900
Monocenter/Multicenter trial: Multicenter trial
National/International: International

end of 1:1-Block recruitment

start of 1:1-Block inclusion criteria

Inclusion Criteria

Gender: Female
Minimum Age: 18 Years
Maximum Age: no maximum age

end of 1:1-Block inclusion criteria

start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

• Informed consent to participate in the study after preceding written and verbal information
• Suspected or confirmed endometriosis with planned surgery within 6 months
• Ability to consent
• Age > 18 years

end of 1:1-Block inclusion criteria add

start of 1:1-Block exclusion criteria

Exclusion Criteria

Inapplicability of the diagnostic procedures routinely provided for preoperative endometriosis-specific knowledge acquisition (e.g. gynecological examination, ultrasound or other imaging)

end of 1:1-Block exclusion criteria

start of 1:n-Block addresses

Addresses

Primary Sponsor
start of 1:1-Block address primary-sponsor
- Kepler Universitätsklinikum
- 4020 Linz
- Austria
end of 1:1-Block address primary-sponsor

start of 1:1-Block address contact primary-sponsor
- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: [---]*
end of 1:1-Block address contact primary-sponsor
Contact for Scientific Queries
start of 1:1-Block address scientific-contact
- Kepler Universitätsklinikum - Universitätsklinik für Gynäkologie, Geburtshilfe und Gyn. Endokrinologie
- Mr. Dr. Simon-Hermann Enzelsberger
- Krankenhausstraße 26-30
- 4020 Linz
- Austria
end of 1:1-Block address scientific-contact

start of 1:1-Block address contact scientific-contact
- Telephone: +43 5 7680 84 23718
- Fax: [---]*
- E-mail: simon-hermann.enzelsberger at kepleruniklinikum.at
- URL: https://www.kepleruniklinikum.at/versorgung/kliniken/gynaekologie-geburtshilfe-und-gyn-endokrinologie
end of 1:1-Block address contact scientific-contact
Contact for Public Queries
start of 1:1-Block address public-contact
- Kepler Universitätsklinikum - Universitätsklinik für Gynäkologie, Geburtshilfe und Gyn. Endokrinologie
- Mr. Dr. Simon-Hermann Enzelsberger
- Krankenhausstraße 26-30
- 4020 Linz
- Austria
end of 1:1-Block address public-contact

start of 1:1-Block address contact public-contact
- Telephone: +43 5 7680 84 23718
- Fax: [---]*
- E-mail: simon-hermann.enzelsberger at kepleruniklinikum.at
- URL: https://www.kepleruniklinikum.at/versorgung/kliniken/gynaekologie-geburtshilfe-und-gyn-endokrinologie
end of 1:1-Block address contact public-contact

end of 1:n-Block addresses

start of 1:n-Block material support

Sources of Monetary or Material Support

Institutional budget, no external funding (budget of sponsor/PI)
start of 1:1-Block address materialSupport
- Kepler Universitätsklinikum
- 4020 Linz
- Austria
end of 1:1-Block address materialSupport

start of 1:1-Block address contact materialSupport
- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: [---]*
end of 1:1-Block address contact materialSupport

end of 1:n-Block material support

start of 1:1-Block state

Status

Recruitment Status: Recruiting complete, follow-up complete
Reason, if "Recruitment stopped after recruiting started" or "Recruiting withdrawn before recruting started": [---]*
Reason, if Reason for Recruiting Stop "Other": [---]*
Study Closing (LPLV): 2019/11/27
Number of Participants in Germany after Recruiting complete: 673
Total Number of Participants (all Sites worldwide) after Recruiting complete: 1144

end of 1:1-Block state

start of 1:n-Block publications

Trial Publications, Results and other Documents

Approval of ethics comm. (mandatory for transfer to Studybox): Positives Ethikvotum

end of 1:n-Block publications

* This entry means the parameter is not applicable or has not been set.